Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT00309218
Eligibility Criteria:
Inclusion Criteria:
* Age \< 18.0 years
* Bone age of boys \< 15 years, of girls \< 13 years
* Patients 12-24 months after renal transplantation with stable transplant function
* First or second kidney transplant, living or cadaver kidney donation
* Triple immunosuppression with cyclosporine (CyA), MMF, and daily steroids at study entry
* Patients and parents, respectively, have given their written consent after enlightenment (informed consent)
Exclusion Criteria:
* Irreversible rejection of former transplant within 6 months
* Highly reactive (\> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation
* Anamnestically steroid-resistant rejection of current transplant
* More than 2 acute rejection reactions prior to study entry (i.e., in the first 12-24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry
* Glomerular filtration rate (GFR) \< 40 ml/min/1.73 m² (Schwartz formula) at study entry
* Acute rejection reaction or unstable transplant function (increase of serum creatinine \> 20%) during the last 6 months before study entry or histologically confirmed chronic rejection reaction
* Suspected insufficient medication compliance
* Patients receiving a basic immunosuppression other than that prescribed in this protocol
* Simultaneous therapy with growth hormone after renal transplantation
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT00309218
Study Brief:
Protocol Section:
NCT00309218